Application Kit for Trial or Study
Please note that as of 1 October 2009 all ethics submissions to the NCAHS HREC will need to be on the National Ethics Application Form (NEAF) and Site Specific Assessment/s (SSA/s) will need to be completed and sent to the relevant NCAHS Research Governance Officer (RGO) (the Management Approval Form will no longer be required). Both the NEAF and SSA are available for completion online at the link below. This link will take you to the Log-In page, if you are not a current user please click on the 'Create Account' tab.
http://www.ethicsform.org/au/SignIn.aspx
NCAHS RGO listing is available at http://int.ncahs.nsw.gov.au/research-ethics/index.php?pageid=3004&siteid=254
Submissions to NCAHS HREC require original (file copy) plus 14 sets of copies (total 15 sets)(Each set of copy documents to be doublesided, stapled or clipped together in the top left hand corner and 2 hole punched - please do not use plastic sleeves or binders)A covering letter is required listing the documents attached, with the version number and date if applicable, for all applications and amendments. The name of the protocol and the investigator brochure should also be included for all Clinical Trials.
FORMS:
Completed NEAF
Application Submission Checklist
Checklist for Informed Consent
For Clinical Trials please read the Guideline: Consent by a third party on behalf of a patient
Submitting an Ethics Application Information:
Does the Study require Ethics Approval or is it Quality Assurance
In order for it to be a QA study you need to be able to answer no (honestly) to all of the questions in Section 5 “Questions to be Considered” on page 9 of the document “When does quality assurance in health care require ethical review” (in this link).
If you answer yes just once then it may require ethical review, however please refer to the section on Negligible Risk-Quality Assurance and the Process for such review. The study may qualify for Regsitering of Negligible Risk Research or Quality Assurance with NCAHS HREC rather than going through a full HREC review.
NCAHS Ethics Therapeutic Good Regulation - Information for Researchers
Privacy Information Sheet for Researchers
Policy for Review and Approval
FORMS required to be completed during/completion of Trial/Study:
Project Annual/Progress Report Form
Ethics Research Trial/Study Completion Form